Cost of drug to prevent premature birth decried

Dose of previously available compound is priced at $1,500

When a drug to prevent babies from being born too early won federal approval in February, many doctors, pregnant women and others cheered the step as a major advance against a heartbreaking tragedy.

Then they saw the price tag.

The list price for the drug, Makena, turned out to be a stunning $1,500 per dose. That's for a drug that must be injected every week for about 20 weeks, meaning it will cost about $30,000 per at-risk pregnancy. If every eligible American woman were to get Makena, the nation's bloated annual health-care tab would swell by more than $4 billion.

What really infuriates patients and doctors is that the same compound has been available for years at a fraction of the cost - about $10 or $20 a shot.

"It's outrageous," said Helain Landy, chairman of obstetrics and gynecology at Georgetown University Hospital. She prescribes a form of the hormone progesterone under the name 17P for some of her patients. "Raising the cost of each injection from around $20 to $1,500 is ludicrous."

The company that owns Makena, KV Pharmaceutical of St. Louis, says the price is reasonable, given that it is spending more than $200 million to develop the drug and conduct follow-up studies that the Food and Drug Administration demands, and because of the savings resulting from preventing preterm births. Through a subsidiary, Ther-Rx Corp., the company created a program to help women who can't afford it.

Critics are challenging that claim, noting that the main study used to demonstrate the drug's effectiveness was a $5 million project conducted by the National Institutes of Health - paid by taxpayers.